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Targeted therapy (TT) in metastatic renal cell carcinoma (mRCC) may be associated with a high rate of toxicity that undermines treatment efficacy and patient quality of life.
The purpose of Phase I designs is to estimate the MTD (maximum tolerated dose, in practice a dose with some given acceptable rate of toxicity) while, at the same time, minimizing the number of patients treated at doses too far removed from the MTD.
This inversion would tell us which dose corresponds to some given rate of toxicity.
The high rate of toxicity militates against its use in the palliative setting.
57 Moreover, the combination treatment was associated with an increased rate of toxicity, especially in Caucasian patients.
By using the formula that was given in Material and Methods section, the rate of toxicity could be calculated.
Similar(39)
Both trials led to similar conclusions and failed to show a benefit in survival for the experimental arm, but reported an increase in haematological and non-haematological toxicity, and a higher rate of toxicity-related death (Mavroudis et al, 2001; Niell et al, 2005).
The treatment of locally advanced or metastatic disease is currently based on the M-VAC regimen (methotrexate, vinblastine, doxorubicin, cisplatin), in spite of a high rate of toxicities.
This may be due to the limited sample size, the high rate of toxicities, and low dose density in our study.
Because of variability in toxicity assessment, prior rates of toxicity may not be reliable when evaluated against a phase II study focusing on toxicity amelioration.
Dose-adapted fractionation schedules seem to have much lower rates of toxicity and prospective trials, including the completed RTOG 0813 study and the on-going EORTC LUNGTEC study, should provide further evidence of safety and establish organ at risk tolerances.
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